A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence

NCT00998790 | Completed Results

• 1 other identifier: MC0602
• Study Type: interventional
• Target: 114
• Locations: 2 countries
• Sites: 3

Brief Summary

A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.

Conditions

Stress Urinary Incontinence

Keywords

Urinary Incontinence, Stress; Intrinsic sphincter deficiency; Secondary; TUR; TURP; Radical prostatectomy; Open prostatectomy; Post-suprapubic prostatectomy

Outcome Measures

Primary Outcomes (4)

• Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up

  1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.

  24 months

• Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up

  24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.

  24 months

• Percentage of Subjects in Each Range of Pads Per Day Use

  Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day

  Baseline

• Percentage of Subjects in Each Range of Pads Per Day Use

  Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day

  24 months

Secondary Outcomes (1)

• To Evaluate Patient Quality of Life

  24 months

Study Arms (1)

AMS AdVance Sling Group

EXPERIMENTAL

European Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.

Device: American Medical Systems (AMS) AdVance™ Male Sling System

Interventions

American Medical Systems (AMS) AdVance™ Male Sling System DEVICE

The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.

Also known as: Device: AdVance Male Sling

AMS AdVance Sling Group

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has agreed to be implanted with the AMS AdVance Male Sling System.
• The subject is willing and able to give valid informed consent.
• The subject is ≥40 years of age.
• The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management and has less than 250 grams on the 24-hour pad weight test.
• The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
• Internal sphincter contractility confirmed by endoscopic view.
• The subject's primary etiology is TUR, TURP, or radical prostatectomy.
• Pre-existing urological conditions, other than incontinence have been treated and are under control.
• The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
• The subject is a good surgical candidate.

You may not qualify if:

• The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
• The subject has a post-void residual ≥ 100 cc.
• The subject has detrusor-external sphincter dyssynergia.
• The subject has a urinary tract infection (UTI).
• The subject was treated with pelvic radiation within the last 6 months.
• The subject currently has an inflatable penile prosthesis.
• The subject self-catheterizes.
• The subject has symptomatic or unstable bladder neck structure disease.
• The subject has a history of urethral strictures that may require repetitive instrumentation.
• The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
• The subject has a history of connective tissue or autoimmune conditions.
• The subject has a compromised immune system.
• The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
• The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Universitaire Ziekenhuisen Leuven

Leuven, Belgium

Location

Clinique Jules Verne

Nantes, Cedex 3, 44314, France

Location

Hopital Edouard Herriot

Lyon, 69435, France

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Pathologic Processes

Results Point of Contact

• Title: Laura Olson, Clinical Project Manager
• Organization: American Medical Systems

laura.olson2@bsci.com

952-930-6428

Study Officials

• Armin Becker, MD

  Oberarzt der Urologischen Klinik Grosshadern

  PRINCIPAL INVESTIGATOR

• Dirk de Ridder, Professor

  UZ Gasthuisberg

  PRINCIPAL INVESTIGATOR

• Pedro Arano, MD

  Fundacion Puigvert

  PRINCIPAL INVESTIGATOR

• Francois Haab, Professor

  Institution Tenon Hospital

  PRINCIPAL INVESTIGATOR

• Olivier Haillot, Professor

  Hopital Bretonneau

  PRINCIPAL INVESTIGATOR

• Philippe Chauveau, MD

  Clinique Jules Verne

  PRINCIPAL INVESTIGATOR

• Hakim Fassi-Fehri, MD

  Hopital Edouard Herriot

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 20, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 22, 2018
• Results First Posted: October 22, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); FR (2)